Pre-Existing Tobacco Products: Update to Term

2022 the center for tobacco products CTP updated the term grandfathered or GF tobacco product to pre-existing or PX tobacco product this change does not affect submissions assigned a GF submission tracking number or stn either currently pending with FDA or those that have already been reviewed and received a determination letter submission tracking numbers will now start with a prefix of PX rather than GF the change from

grandfathered to pre-existing is a change in terminology a pre-existing tobacco product has the same definition as a grandfathered tobacco product the terminology was updated in support of ctp's ongoing commitment to diversity Equity inclusion and accessibility the term grandfathered when used to describe someone or something exempt from a new law or regulation has its roots in 19th century racist voting laws therefore it was updated to the

more appropriate term pre-existing notice of this change was also provided in the pre-market tobacco product application or pmta and substantial equivalence or SE final rules wherein the term was changed from grandfathered tobacco product to pre-existing tobacco product because it more appropriately describes these products by using the more precise pre-existing in place of grandfathered as of august 19 2022 official updates have been made to the terminology

in both e-submitter and CTP electronic submission applications to replaced grandfathered with pre-existing users will no longer be able to select grandfathered as an option users of both systems will not encounter major changes due to the terminology update further the CTP Standalone pre-existing tobacco product determinations database will show both the tobacco products previously assigned GF stns and the tobacco products with new PX stns existing submission tracking

numbers or stns will not be changed as a result pending or completed submissions prior to august 19 2022 do not need to be resubmitted or amended due to the terminology change a submission assigned a GF stn will not be retroactively changed to a px stn it will retain the original gfstn it was assigned no action needs to be taken on behalf of the firm and there

is no need to contact CTP to change or update stns applicants with a pending or previously authorized substantial equivalence SE report that references a GF product are not required to take any additional actions based on this terminology change CTP also plans to update any guidance documents that previously included the term grandfathered tobacco product the center will announce the availability of the revised final guidance for industry

collectively entitled pre-existing tobacco product guidance documents via the Federal Register in the future the email address for the pre-existing tobacco product determination program has been updated from CTP Dash grandfather to CTP Dash pre-existing at fda.hhs.gov please send all correspondence to this updated email address as the previous grandfather email is no longer in use you will see the new email box listed in correspondence from CTP in

regards to the voluntary pre-existing mailbox please see the resources noted on this slide if you would like more information on ctp's pre-existing tobacco product program thank you for watching [Music]